Katalyst CRO
Overview
Regulatory Affairs Consultant role at Katalyst CRO. The position involves developing global regulatory strategies for medical device products, collaborating across a matrixed organization to ensure successful global product registrations, and providing regulatory leadership across the product lifecycle. Responsibilities
Develop global regulatory strategies for medical device products to meet business objectives and collaborate across a matrixed organization to ensure global success of product registrations. Participate on product development teams, providing regulatory strategies, timelines, and direction. Review and approve technical documentation. Negotiate with regulatory authorities to resolve questions or issues that arise during the product lifecycle. Drive product change assessments and define regulatory impact of product changes in global markets. Review and approve labeling, training, promotional, and advertising material. Maintain Regulatory Affairs product files and ensure compliance with regulatory requirements. Participate on audit and field action teams and support other post-market activities. Facilitate and prepare U.S. regulatory Pre-Submission documents and pre-submission meetings. Regulatory expert support for IVDR teams; implement regulatory strategies for IVDR activities; collaborate with regulatory staff from other units and agencies to develop harmonized policies, procedures, and work instructions for IVDR compliance. Prepare documents vital for new product market clearance, approval, and lifecycle management (including 510(k)s, PMAs/De Novo, and CE marking technical files). Support global regulatory registration representatives for product global registration activities. Keep abreast of new or revised regulations, guidelines, inspection reports, journals, meetings, etc. Conduct trainings and communicate materials to enhance the team\'s knowledge of working in a regulated environment. Assist Regulatory department in updating, improving, and creating internal policies and procedures. Participate in business meetings with external partners as needed. Participate in inspections/audits by notified bodies or other international regulatory bodies by producing requested documents or answering inquiries for information. Requirements
Minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science. Minimum 5 years of IVD Regulatory Affairs experience, including 510(k), De Novo, PMA, PMA supplement submissions. Experience as the RA representative on project core teams providing active regulatory guidance and RA strategies. Excellent knowledge of U.S. and European/International regulations and standards. RAPS Regulatory Affairs Certification (RAC). Experience interacting with FDA and/or other regulatory agencies. Experience reviewing design specifications and other technical documents. Previous experience in EU MDD/IVDD or MDR/IVDR. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Seniority level
Associate Employment type
Contract Job function
Legal Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr
Regulatory Affairs Consultant role at Katalyst CRO. The position involves developing global regulatory strategies for medical device products, collaborating across a matrixed organization to ensure successful global product registrations, and providing regulatory leadership across the product lifecycle. Responsibilities
Develop global regulatory strategies for medical device products to meet business objectives and collaborate across a matrixed organization to ensure global success of product registrations. Participate on product development teams, providing regulatory strategies, timelines, and direction. Review and approve technical documentation. Negotiate with regulatory authorities to resolve questions or issues that arise during the product lifecycle. Drive product change assessments and define regulatory impact of product changes in global markets. Review and approve labeling, training, promotional, and advertising material. Maintain Regulatory Affairs product files and ensure compliance with regulatory requirements. Participate on audit and field action teams and support other post-market activities. Facilitate and prepare U.S. regulatory Pre-Submission documents and pre-submission meetings. Regulatory expert support for IVDR teams; implement regulatory strategies for IVDR activities; collaborate with regulatory staff from other units and agencies to develop harmonized policies, procedures, and work instructions for IVDR compliance. Prepare documents vital for new product market clearance, approval, and lifecycle management (including 510(k)s, PMAs/De Novo, and CE marking technical files). Support global regulatory registration representatives for product global registration activities. Keep abreast of new or revised regulations, guidelines, inspection reports, journals, meetings, etc. Conduct trainings and communicate materials to enhance the team\'s knowledge of working in a regulated environment. Assist Regulatory department in updating, improving, and creating internal policies and procedures. Participate in business meetings with external partners as needed. Participate in inspections/audits by notified bodies or other international regulatory bodies by producing requested documents or answering inquiries for information. Requirements
Minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science. Minimum 5 years of IVD Regulatory Affairs experience, including 510(k), De Novo, PMA, PMA supplement submissions. Experience as the RA representative on project core teams providing active regulatory guidance and RA strategies. Excellent knowledge of U.S. and European/International regulations and standards. RAPS Regulatory Affairs Certification (RAC). Experience interacting with FDA and/or other regulatory agencies. Experience reviewing design specifications and other technical documents. Previous experience in EU MDD/IVDD or MDR/IVDR. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Seniority level
Associate Employment type
Contract Job function
Legal Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr